Study Finds Pradaxa Significantly Increases Risk of Bleeding

New blood thinner Pradaxa has been linked to serious bleeding events across the world, some resulting even in death. The Food & Drug Administration (FDA) has said that it will conduct studies on Pradaxa, but that for now its benefits outweigh the potential safety risks it poses.

But a recent study published in the Journal of the American College of Cardiology suggests that Pradaxa, generic name dabigatran, is more dangerous than its older counterpart, Warfarin.

In the study, researchers followed 290 patients, half of them taking Pradaxa, and half of them taking Warfarin. The mean age of the patients was 60 years old, and more than three-quarters of them were male.

After following the patients for a year, the authors of the study found that the patients who used Pradaxa experienced more thromboembolic complications (like blood clots) and major bleeding complications. In fact, of those patients taking Pradaxa, three experienced a thromboembolic complication, while none of the patients on Warfain experienced a thromboembolic complication. Similarly, nine of the patients taking Pradaxa experienced major bleeding complications, compared to just one patient who experienced the same complication while taking Warfarin.

Overall, patients taking Pradaxa had a higher bleeding rate, a higher total bleeding rate, and a higher rate of experiencing complications while taking the drug, as compared to the patients taking Warfarin.

Although the study conducted was relatively small and observational in nature, the authors noted that there is a scarcity of data on how Pradaxa affects patients. They called for further studies to be conducted to determine what effects the drug will have on a larger population.

In all, the authors concluded that use of Pradaxa in patients undergoing atrial fibrillation ablation “significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted Warfarin therapy."

The study reinforces the claims of patients who have experienced serious bleeding events while taking Pradaxa and underscores the need for the FDA to not rush drug approvals, as it arguably did with Pradaxa.

If you or a loved one experienced a serious bleeding event while taking Pradaxa, please call experienced dangerous drug attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082 to learn more about your legal rights.